Objective To determine the effects of community occupational therapy on the daily performance of older patients with mild to moderate dementia and the sense of competence of their primary caregivers.

Methods

design: a randomized controlled single-blind design is used with 3 measurement moments. We measure at baseline (before start of OT intervention), after 6 weeks (the effect measurement)and after 3 months after baseline (follow-up measurement).

patients: 135 patients and their primary caregivers are needed to determine effects on the primary outcome measures of this intervention, with a power of 80% and alpha = 0.05/3. This power calculation is based on the outcomes of a pilot study (Graff, et al., 2003).

intervention: 5 weeks client-centered community occupational therapy directed at both patients and primary caregivers using an OT guideline.The control group receives no OT intervention, but usual care.

Analysis: analyses of covariance on intention-to-treat basis (Last Observation Carried Forward (LCOF))will be used to determine the effects of community OT on the daily performance of older patients with dementia and the sense of competence of their primary caregivers. Also secondary patients'and caregivers' health outcomes will be analyzed by analyses of covariance on intention-to-treat basis.

Cost-effectiveness: the costs of this OT intervention will also be determined and a cost-effectiveness analysis will be carried out.

3)Results: Results at baseline, at 6 weeks and at 3 months follow-up on primary outcome measures and on patients' and caregivers' secondary health outcomes and also the cost effectiveness of this intervention, will be analyzed and described in international publications.

Eligibility

Ages Eligible for Study:

65 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

aged 65 years or older

mild to moderate dementia (MMSE 10-24)

living in the community at maximum of 50 kilometers from the Memory Clinic

having an informal primary caregiver who was involved in the care for the patient at least once a week

Exclusion Criteria:

depression: score > 12 on the Geriatric Depression Scale

severe behavioral or psychological symptoms in dementia (BPSD) judged by a geriatrician

severe illnesses, judged by a geriatrician

no OT goals, determined by the researcher or research assistant

caregivers having severe illnesses

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00295152

Graff MJL, et al.Occupational therapy at home for older individuals with mild to moderate cognitive impairments and their primary caregivers: a pilot study. Occupational Therapy Journal of Research 23, 155-163, 2003.